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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR008877 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to compare the effects of polestriding (walking with poles) and traditional walking on physical endurance in subjects with poor circulation in their legs. Another goal is to evaluate the effectiveness of a walking program in increasing the amount of oxygen in the calf muscles and therefore improving overall physical activity and quality of life.
Peripheral Arterial Disease (PAD/PVD) is caused by decreased blood flow to the legs. The most common symptom is intermittent claudication pain during walking that is relieved by rest. Walking is the primary treatment prescribed for PAD rehabilitation. Polestriding uses muscles of the upper and lower body in a continuous movement. Walking with poles increases stride length, cadence and walking speed and decreases ground reaction forces on the joints. Subjects in this study will participate in a walking program with or without poles.
Dr. Collins' research focuses on physical activity interventions to improve the functional status of persons with chronic illness. Several rehabilitation studies have tested the efficacy of walking exercise for patients with PAD. Studies on polestriding indicate that it may be superior to traditional walking, but these two methods have never been compared. Approximately 30% of patients with coronary artery disease have PAD as their only symptom. As the population ages and more people are affected by this debilitating condition, nurse-initiated rehabilitative therapies, such as polestriding, need to be explored. The consent form explains the purpose of the study in addition to the procedures, risks, benefits, options, confidentiality, costs, and compensation. Participants are also asked to sign a HIPPA authorization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking with Poles | Experimental | Patients were assigned to a 24 week walking with poles program of rehabilitation. The intervention was the additional of poles to the walking program. |
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| Traditional walking program | Active Comparator | Patients were assigned to a 24 week traditional walking program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking with poles | Behavioral | Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test | Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97). | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Claudication Pain During Constant Work Rate Treadmill Test | Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded. | At 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen Collins, RN, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital | Hines | Illinois | 60141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15870588 | Background | Collins EG, Langbein WE, Orebaugh C, Bammert C, Hanson K, Reda D, Edwards LC, Littooy FN. Cardiovascular training effect associated with polestriding exercise in patients with peripheral arterial disease. J Cardiovasc Nurs. 2005 May-Jun;20(3):177-85. doi: 10.1097/00005082-200505000-00009. | |
| 12618567 | Background | Collins EG, Edwin Langbein W, Orebaugh C, Bammert C, Hanson K, Reda D, Edwards LC, Littooy FN. PoleStriding exercise and vitamin E for management of peripheral vascular disease. Med Sci Sports Exerc. 2003 Mar;35(3):384-93. doi: 10.1249/01.MSS.0000053658.82687.FF. |
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Patients were screened prior to randomization. Patients were disqualified from the study due to coronary arterial disease, they changed their mind, other medical reasons or it was found that they did not have periphaeral arterial disease.
Patients were recruited at University of Illinois at Chicago, the Edward Hines Jr., VA Hospital, through radio and print advertising. 146 patients were enrolled in the study and 103 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Walking With Poles | Patients exercised using walking poles, 3 times weekly for 24 weeks. |
| FG001 | Traditional Walking Group | Patients exercised for 24 weeks as part of a traditional walking training group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Walking With Poles | Patients exercised using walking poles, 3 times weekly for 24 weeks. |
| BG001 | Traditional Walking Group | Patients exercised for 24 weeks as part of a traditional walking training group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test | Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97). | Data were analyzed on patients with at least 1 follow-up treadmill test from baseline. | Posted | Mean | Standard Deviation | minutes | Baseline and 24 weeks |
|
Adverse events were collected for 32 weeks (the duration of the study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Walking With Poles | Patients exercised using walking poles, 3 times weekly for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Social circumstances | Systematic Assessment |
Due to the small number of women in the trial, results cannot be generalized to women.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eileen G. Collins PhD, RN | University of Illinois at Chicago | 312-413-5621 | ecollins@uic.edu |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016138 | Walking |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Walking exercise | Behavioral | Patients walked for 20-45 minutes, 3 times/week for 24 weeks. |
|
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| 12021703 | Background | Langbein WE, Collins EG, Orebaugh C, Maloney C, Williams KJ, Littooy FN, Edwards LC. Increasing exercise tolerance of persons limited by claudication pain using polestriding. J Vasc Surg. 2002 May;35(5):887-93. doi: 10.1067/mva.2002.123756. |
| 22495802 | Result | Fritschi C, Collins EG, O'Connell S, McBurney C, Butler J, Edwards L. The effects of smoking status on walking ability and health-related quality of life in patients with peripheral arterial disease. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):380-6. doi: 10.1097/JCN.0b013e31824af587. |
| 23050152 | Result | Collins EG, McBurney C, Butler J, Jelinek C, O'Connell S, Fritschi C, Reda D. The Effects of Walking or Walking-with-Poles Training on Tissue Oxygenation in Patients with Peripheral Arterial Disease. Int J Vasc Med. 2012;2012:985025. doi: 10.1155/2012/985025. Epub 2012 Sep 25. |
| 22595894 | Result | Collins EG, O'connell S, McBurney C, Jelinek C, Butler J, Reda D, Gerber BS, Hurt C, Grabiner M. Comparison of walking with poles and traditional walking for peripheral arterial disease rehabilitation. J Cardiopulm Rehabil Prev. 2012 Jul-Aug;32(4):210-8. doi: 10.1097/HCR.0b013e31825828f4. |
| Compliance |
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| Moved |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients exercised for 24 weeks as part of a traditional walking training group. |
|
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| Secondary | Onset of Claudication Pain During Constant Work Rate Treadmill Test | Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded. | Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test. | Posted | Mean | Standard Deviation | minutes | At 24 weeks |
|
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| 4 |
| 51 |
| 2 |
| 52 |
| EG001 | Traditional Walking Group | Patients exercised for 24 weeks as part of a traditional walking training group. | 6 | 52 | 3 | 51 |
| Hospitalization respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Includes hospitalizations for pnemonia and upper respiratory tract infections. |
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| Hospitalization renal disease | Renal and urinary disorders | Non-systematic Assessment | Patient hospitalized for acute renal failure. |
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| Hospitalization cardiac related | Cardiac disorders | Non-systematic Assessment |
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| Hospitalization bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Hospitalization low blood sugar | Endocrine disorders | Non-systematic Assessment |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D009043 | Motor Activity |